Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K8/00—Cosmetics or similar toiletry preparations
  • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
  • A61K8/96—Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution
  • A61K8/965—Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution of inanimate origin
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
  • A61Q17/00—Barrier preparations; Preparations brought into direct contact with the skin for affording protection against external influences, e.g. sunlight, X-rays or other harmful rays, corrosive materials, bacteria or insect stings
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K2800/00—Properties of cosmetic compositions or active ingredients thereof or formulation aids used therein and process related aspects
  • A61K2800/74—Biological properties of particular ingredients
  • A61K2800/75—Anti-irritant

Definitions

• the present invention relates to a method of reducing eye irritation in cosmetic compositions.
• Cosmetics such as facial moisturizing creams and lotions, sunscreen compositions, and shampoos are often applied near the eye. These compositions can come into contact with the eye either during application, following subsequent rubbing of around the eye, or as a result of perspiration. As the eye only has an epithelial barrier, it is more sensitive to cosmetic compositions than the skin, which possesses both a stratum corneum and epidermal barrier layers. Thus, compositions that are otherwise non-irritating to the skin can often irritate, e.g., sting, the eye.
• the present invention relates to a method of reducing eye irritation in cosmetic compositions by adding mineral water, e.g., in place of some or all of the distilled water.
• the invention features a method of reducing eye irritation such eye redness (e.g., the appearance of blood vessles in the eye) or eye sting (e.g., pain in the eye), caused by a cosmetic composition, comprising incorporating a reducing amount of mineral water into the cosmetic composition.
• the method reduces the eye irritation, sting, or redness of the composition by at least about 5% such as at least about 20%.
• the present invention relates to a method of reducing eye irritation caused by a cosmetic composition comprising incorporating mineral water into said cosmetic composition.
• mineral water is water having mineralization (i.e., the sum of the concentrations of anions and cations present in the water) of at least about 200 mg/L (e.g., at least about 300 mg/L such from about 400 mg/L to about 1000 mg/L).
• mineralization i.e., the sum of the concentrations of anions and cations present in the water
• examples of such anions and cations include, but are not limited to, calcium, magnesium, bicarbonates, sulfates, potassium, sodium, chlorides, nitrates, phosphates, lithium, manganese, sulfites, fluoride, and iodide.
• the mineral water has at least about 5 mg/L, e.g., at least about 10 mg/L, of magnesium and at least about 10 mg/L of calcium, e.g., at least about 20 mg/L.
• the mineral water may be a naturally mineralized water, e.g., a mineral water suitable for consumption, or a thermal spring water, which is often not consumable.
• mineral water include, but are not limited to, eau d'Evian (Evian Eau Minerale Naturelle or Evian® Natural Spring Water referred herein as Evian® Mineral Water), eau Volvic, and eaux de Vittel (e.g., Grande Spring or Hepar Spring).
• thermal spring waters examples include eau de la Bourboule, eau d'Enghien-les-bains, eau d'Allevard-les-bains, eau de Digne, eau des Maizieres, eau de Nyrac-les-bains, eau de Lons le Saunier, Eaux Bonnes, eau de Rochefort, eau de Saint Christau, eau des Fumades, eau de Tereau de Vittel, eaux du bassin de Vichy, eau d'Uriage, eau d'Avene, and eau de la Roche Posay.
• the mineral water comprises (a) from about 30 mg/L to about 150 mg/L of calcium; (b) from about 10 mg/L to about 50 mg/L of magnesium; (c) from about 150 mg/L to about 700 mg/L of bicarbonates; (d) from about 0.1 mg/L to about 5 mg/L of potassium; (e) from about 1 to about 20 mg/L of sulfates; (f) from about 1 to about 10 mg/L of sodium; (g) from about 1 mg/L to about 10 mg/L of chlorides; and (h) from about 1 mg/L to about 10 mg/L of nitrates.
• the mineral water is Evian® Mineral Water that comprises: (a) about 78 mg/L of calcium; (b) about 24 mg/L of magnesium, (c) about 357 mg/L of bicarbonates; (d) about 1 mg/L of potassium; (e) about 10 mg/L of sulfates; (f) about 5 mg/L of sodium, (g) about 4 mg/L of chlorides; and (h) from about 1 to about 4 mg/L nitrates.
• Evian® Mineral Water that comprises: (a) about 78 mg/L of calcium; (b) about 24 mg/L of magnesium, (c) about 357 mg/L of bicarbonates; (d) about 1 mg/L of potassium; (e) about 10 mg/L of sulfates; (f) about 5 mg/L of sodium, (g) about 4 mg/L of chlorides; and (h) from about 1 to about 4 mg/L nitrates.
• the composition comprises at least about 1%, by weight, of mineral water, e.g. about 10% to about 99%, by weight, of mineral water.
• compositions of the present invention may further comprise one or more of the following compounds: creatine, carnitine, or pyruvic acid, or a cosmetically acceptable salt or ester thereof.
• cosmetically acceptable salt or ester is one that does not eliminate the therapeutic benefit of the compound (e.g., its hydrating, nourishing, metabolic enhancing properties).
• cosmetically acceptable salts include, but are not limited to, those with cosmetically acceptable organic acids (e.g., acetic, lactic, maleic, citric, malic, ascorbic, succinic, benzoic, methesulfonic, toluenesulfonic, or pamoic acid), as well as polymeric acids (e.g., tannic or carboxymethyl cellulose) and salts with inorganic acids such as a hydrohalic acid (e.g., hydrochloric acid, sulfuric acid, or phosphoric acid).
• cosmetically acceptable esters include, but are not limited to, C2-C6 alkyl esters such as methyl esters and ethyl esters.
• Examples of such compounds include, but are not limited to, creatine monohydrate, creatine hemisulfate, D-carnitine, L-carnitine, L-carnitine hydrochloride, sodium pyruvate, and pyruvic acid methyl ester. As used herein, if the stereochemistry of the compound is not indicated, then the compound includes all stereoisomers, if any.
• the amount of carnitine or a cosmetically acceptable salt or ester thereof, creatine or a cosmetically acceptable salt or ester thereof, or pyruvic acid or a cosmetically acceptable salt or ester thereof, in the composition varies (e.g., depending on the intended use or the form of the composition) being administered and will typically be present in the composition in an amount from about 0.001% to about 10%, by weight, of the topically applied composition, e.g., from about 0.01% to about 5%, by weight, such as from about 0.01% to about 1%, by weight, of such carnitine, creatine, pyruvic acid or cosmetically acceptable salt or ester thereof.
• the method further comprises administering (e.g., in a composition) another cosmetically active agent.
• a cosmetically active agent is a compound that has a cosmetic or therapeutic effect on the skin, e.g., agents to treat wrinkles, acne, or to lighten the skin.
• the agent is selected from, but not limited to the group consisting of hydroxy acids, benzoyl peroxide, sulfur resorcinol, ascorbic acid, D-panthenol, hydroquinone, sunscreen agents, anti-inflammatory agents, skin lightening agents, antimicrobial and antifungal agents, estrogens, 2-dimethylaminoethanol, lipoic acid, amino acids such a proline and tyrosine, lactobionic acid, acetyl-coenzyme A, niacin, riboflavin, thiamin, ribose, electron transporters such as NADH and FADH2, botanical extracts such as aloe vera and soy, and derivatives and mixtures thereof.
• the cosmetically active agent will typically be present in the composition of the invention in an amount of from about 0.001% to about 20% by weight of the composition, e.g., about 0.01% to about 10% such as about 0.1% to about 5%.
• hydroxy acids include, but are not limited, to (i) alpha-hydroxy acids such as glycolic acid, lactic acid, malic acid, citric acid, and tartaric acid, (ii) beta-hydroxy acids such as salicylic acid, and/or (iii) polyhydroxy acids. See, e.g., European Patent Application No. 273,202.
• derivatives of ascorbic acid include, but are not limited to, ascorbyl palmitate, magnesium ascorbyl phosphate, sodium ascorbyl phosphate, zinc ascorbyl phosphate, ascorbyl glucoside, sodium ascorbate, and ascorbyl polypeptide.
• An example of a derivative of hydroquinone includes, but is not limited to, arbutin.
• compositions useful in the subject invention involve formulations suitable for topical application to mammalian skin, the formulation comprising (i) mineral water, (ii) optionally, a safe and effective amount of the creatine, carnitine, or pyruvic acid, or a cosmetically acceptable salt or ester thereof or another cosmetically active agent(s), and (iii) optionally, a cosmetically-acceptable topical carrier.
• cosmetically-acceptable topical carrier refers to a carrier for topical use that is capable of having the mineral water and any other agents dispersed or dissolved therein, and possessing acceptable safety properties.
• the cosmetically-acceptable carrier comprises mineral water (e.g., an emulsion where the aqueous phase comprises mineral water or a mineral water based cleanser or spray).
• compositions useful in the present invention may be used for a variety of cosmetic uses, including, but not limited to, treating, cleansing, beautifying, or covering the skin or hair of a human.
• the compositions thus, may be made into a wide variety of product types. These include, but are not limited to cleansers (e.g., facial scrubs), shampoos, lotions, creams, gels, sticks, sprays, ointments, pastes, mousses, shampoos, cosmetics, and dermal patches. Examples include lip balms, moisturizing and sunscreen lotions/creams, skin cleansing compositions, and body mists.
• These products may comprise several types of carrier systems including, but not limited to single phase solutions (e.g., water/mineral water or oil based solutions), emulsions, and gels.
• compositions useful in the present invention formulated as solutions typically include a cosmetically acceptable aqueous (e.g., mineral water) and/or organic carriers (e.g., from about 80% to about 99.99%, by weight of the composition, such as from about 90% to about 99%, by weight of the composition, of an acceptable aqueous or organic solvent).
• a cosmetically acceptable aqueous e.g., mineral water
• organic carriers e.g., from about 80% to about 99.99%, by weight of the composition, such as from about 90% to about 99%, by weight of the composition, of an acceptable aqueous or organic solvent.
• suitable organic solvents include: propylene glycol, polyethylene glycol (200-600), polypropylene glycol (425-2025), glycerol, 1,2,4-butanetriol, sorbitol esters, 1,2,6-hexanetriol, ethanol, isopropanol, butanetriol, sorbitol esters, 1,2,6-hexanetriol, butanediol, and mixtures thereof.
• a propellant is added to a solution composition.
• propellants useful herein include, but are not limited to, chlorinated, fluorinated, and chloro-fluorinated lower molecular weight hydrocarbons.
• Other propellants useful herein can be found in Sagafin, Cosmetics Science and Technology, 2nd Edition, Vol. 2, pp. 443-65 (1972) (hereinafter "Sagafin") and the ICI Handbook pp. 1655.
• a lotion can be made from a solution carrier system.
• Lotions typically comprise from about 1% to about 20% by weight of the composition (e.g., from about 5% to about 10%) of an emollient(s) and from about 50% to about 90% by weight of the composition (e.g., from about 60% to about 80%) of water (e.g., mineral water).
• a cream typically comprises from about 5% to about 50% by weight of the composition (e.g., from about 10% to about 20%) of an emollient(s) and from about 45% to about 85% by weight of the composition (e.g., from about 50% to about 75%) of water (e.g., mineral water).
• water e.g., mineral water
• An ointment may comprise a simple base of animal or vegetable oils or semi-solid hydrocarbons. Ointments may also comprise absorption ointment bases that absorb water to form emulsions. Ointment carriers may also be water-soluble. An ointment may comprise from about 1% to about 20% by weight of the composition of an emollient(s) plus from about 0.1% to about 2% by weight of the composition of a thickening agent(s). A more complete disclosure of thickening agents or viscosity increasing agents useful herein can be found in Sagafin pp. 72-73 and the ICI Handbook pp. 1693-97.
• the carrier is formulated as an emulsion (e.g., an oil-in-water, silicone-in-water, water-in-oil, or water-in-silicone emulsion), from about 1% to about 10% by weight of the composition (e.g., from about 2% to about 5%) of the carrier system may comprise an emulsifier(s).
• Emulsifiers may be nonionic, anionic, cationic, or zwitterionic. Suitable emulsifiers are disclosed in, for example, U.S. Patent No. 3,755,560, U.S. Patent No. 4,421,769, McCutcheon's Detergents and Emulsifiers, North American Edition, pp. 317-24 (1986), and the ICI Handbook, pp.1673-86.
• Lotions and creams can also be formulated as emulsions.
• emulsions may comprise from 0.5% to about 5% by weight of the composition of an emulsifier(s).
• Creams may typically comprise from about 1% to about 20% by weight of the composition (e.g., from about 5% to about 10%) of an emollient(s); from about 20% to about 80% by weight of the composition (e.g., from 30% to about 70%) of water (e.g., mineral water); and from about 1% to about 10% by weight of the composition (e.g., from about 2% to about 5%) of an emulsifier(s).
• Triphase emulsion compositions such as the water-in-oil-in-water type, as disclosed in U.S. Patent No. 4,254,105, are also useful in the subject invention.
• such triphase emulsions contain water, emollients, and emulsifiers as essential ingredients.
• Triple emulsion carrier systems comprising an oil-in-water-in-silicone fluid emulsion composition, as disclosed in U.S. Patent No. 4,960,764, may also be useful in the subject invention.
• the methods of the present invention may also comprise administering a composition containing one or more of the following: antioxidants (e.g., ascorbic acid, tocopherols, polyphenols, tocotrienols, BHA, and BHT), chelating agents (e.g., EDTA), and preservatives (e.g., parabens).
• antioxidants e.g., ascorbic acid, tocopherols, polyphenols, tocotrienols, BHA, and BHT
• chelating agents e.g., EDTA
• preservatives e.g., parabens
• suitable antioxidants, preservatives, and chelating agents are listed in pp. 1612-13, 1626, and 1654-55 of the ICI Handbook.
• the topical compositions useful herein can contain conventional cosmetic adjuvants, such as dyes, opacifiers (e.g., titanium dioxide), pigments, and fragrances.
• compositions and cosmetic formulations for use in the methods of the present invention may be prepared using methodology that is well known by an artisan of ordinary skill. The following is a description of the testing and manufacturing of cosmetic compositions of the present invention.
• Example 1 Mineral Water Containing Carnitine, Trehalose, and Sodium Pyruvate
• a composition containing Evian® Mineral Water (Evian, France), carnitine, sodium pyruvate, and trehalose was manufactured using the ingredients listed in Table I.
• the mineral water was first heated to 30°C. The other ingredients were then added and dissolved one by one under mixing conditions.
• the pentylene glycol was obtained from Dragoco Gerberding & Co. (Holzminden, Germany) under the tradename Hydrolite® -5.
• a skin cleansing emulsion composition containing the composition of Example 1 was manufactured using the ingredients listed in Table II.
• INGREDIENTS % WEIGHT Oil Phase Ingredients Isononyl Isononanoate 2 Cyclomethicone 2 Isostearyl Palmitate 2 Cetyl Octanoate 2 Pentaerythritol Tetraoctanoate 2 Tocopheryl Acetate 0.01 Evening Primrose Oil 0.01 Water Phase Ingredients Mineral Water q.s.
• the mineral water (Evian® Mineral Water, Evian, France) and the disodium EDTA were heated to 85°C, and heat was maintained for about 15 min.
• the carbomer (Carbopol Ultrez® 10 from BF Goodrich Performance Materials, Consumer Specialties Group, Cleveland OH) was slowly added to the mixture and mixed for about 20 min. The mixture was then cooled to 65°C, following which the Peg-6 caprylic-capric glycerides (Tegosoft® GMC6 from Tegasoft Co., Th Goldschmit AG, Essen, Germany), sucrose cocoate, hexylene glycol, methyl paraben, and propyl paraben were added.
• the Peg-6 caprylic-capric glycerides (Tegosoft® GMC6 from Tegasoft Co., Th Goldschmit AG, Essen, Germany), sucrose cocoate, hexylene glycol, methyl paraben, and propyl paraben were added.
• the Oil Phase Ingredients were mixed and heated to 60°C (with the tocopheryl acetate and evening primrose oil being added just before mixing with the mixture in the first beaker).
• the mixture of the second beaker was added to the water phase and mixed for about 15 min.
• the mixture was then neutralized with the 20% sodium hydroxide aqueous solution and mixed until uniform.
• the mixture was then cooled to 35°C, and the sodium pyruvate, carnitine, Arnica Montana Extract/ Propylene Glycol/ Water (Vegetol Arnica MCF 115 Hydro® from Gattefosse SA, Saint Priest Cedex, France), and the composition of Example 1 were added. Finally, the fragrance was then added to the resulting mixture.
• Damage to the permeability barrier is quantified by measuring the amount of marker dye, sodium fluorescein, which leaked across a layer of MDCK cells grown on a microporous filter, to the lower well. Damage is assessed over a range of test composition concentrations. The amount of dye leakage following exposure to each concentration is determined spectrophotometrically by measuring the optical density (490nm).
• Reduction of ocular irritation was measured in the following six different products- (i) the composition of Example 2, (ii) the composition of Example 2 wherein the mineral water was replaced with distilled water; (iii) a composition of Example 3; (iv) the same composition of Example 2 except that the mineral water was replaced with distilled water; (v) Johnson's Baby Shampco® ("JBS") (Johnson & Johnson Consumer Companies, Inc., Skillman, NJ); and (vi) Johnson's Baby Shampoo except that the mineral water was replaced with distilled water.
• JBS Johnson's Baby Shampco®
• leakage was plotted against concentration, and a mean EC 50 value was determined by probit analysis as set forth in the Table III.
• Example 2 For the composition of Example 2, the formulations with either distilled water or mineral water were both mild, so optical density at full concentration was measured as set forth in Table IV. Composition %of Maximum Leakage Example 2 (Distilled Water) 56 Example 2 (Mineral Water) 48

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